Tissue anchor for heart implant

ABSTRACT

An anchor of an implant is transluminally advanced to a heart of a subject, the anchor including a distal helical element, and a post extending proximally from the distal helical element. The implant is anchored to tissue of the heart by driving the distal helical element into tissue of the heart, and compressing a fabric tube against the tissue by moving an annular member, coupled to the post, toward the tissue such that the fabric tube becomes sandwiched between the annular member and the tissue. Other embodiments are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/159,621 to Miller et al., entitled “ Tissue anchor forannuloplasty device,” filed Oct. 13, 2018, which published as US2019/0046318;

-   -   which is a continuation application of U.S. patent application        Ser. No. 15/208,253 to Miller et al., entitled, “Tissue anchor        for annuloplasty device,” filed on Jul. 12, 2016, which issued        as U.S. Pat. No. 10,098,737;    -   which is a continuation application of U.S. patent application        Ser. No. 14/667,090 to Miller et al., entitled, “Tissue anchor        for annuloplasty device,” filed on Mar. 24, 2015, which issued        as U.S. Pat. No. 9,414,921;    -   which is a continuation application of U.S. patent application        Ser. No. 13/504,870 to Miller et al., entitled, “Tissue anchor        for annuloplasty device,” filed on Jul. 19, 2012, which issued        as U.S. Pat. No. 9,011,520;    -   which is the US National Phase of International Patent        Application PCT/IL2010/000890 to Miller et al., entitled,        “Tissue anchor for annuloplasty device,” filed on Oct. 28, 2010,        which published as WO 2011/051942;    -   which claims priority from and is a continuation-in-part of U.S.        patent application Ser. No. 12/608,316 to Miller et al.,        entitled, “Tissue anchor for annuloplasty device,” filed on Oct.        29, 2009, which issued as U.S. Pat. No. 8,277,502.

All of these applications and patents are assigned to the assignee ofthe present application and are incorporated herein by reference.

FIELD OF THE INVENTION

Some applications of the present invention relate in general to tissueanchors. More specifically, some applications of the present inventionrelate to tissue anchors for repair of an atrioventricular valve of apatient.

BACKGROUND OF THE INVENTION

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

US Patent Application 2004/0236419 to Milo describes methods forreconfiguring an atrioventricular heart valve that may use systemscomprising a partial or complete annuloplasty rings proportioned toreconfigure a heart valve that has become in some way incompetent, apair of trigonal sutures or implantable anchors, and a plurality ofstaples which may have pairs of legs that are sized and shaped forassociation with the ring at spaced locations along its length. Thesesystems permit relative axial movement between the staples and the ring,whereby a patient's heart valve can be reconfigured in a manner thatdoes not deter subtle shifting of the native valve components.Shape-memory alloy material staples may have legs with free ends thatinterlock following implantation. Annuloplasty rings may be complete orpartial and may be fenestrated. One alternative method routes a flexiblewire, preferably of shape-memory material, through the bights ofpre-implanted staples. Other alternative systems use linkers ofshape-memory material having hooked ends to interengage with staples orother implanted supports which, following implantation, decrease ineffective length and pull the staples or other supports toward oneanother so as to create desired curvature of the reconfigured valve.These linkers may be separate from the supports or may be integral withthem and may have a variety of shapes and forms. Various of thesesystems may be implanted non-invasively using a delivery catheter.

US 2007/0049942 to Hindrichs et al. describes remodeling a soft bodytissue structure by shortening the distance between first and secondportions of that tissue structure. First and second anchor structuresare respectively implanted in the first and second portions of thetissue structure. These anchor structures are linked by a linkingstructure, the length of which between the anchor structures can beshortened to pull the tissue structure portions toward one another. Eachof the anchor structures may include two screw structures that aredriven into the associated tissue structure portion transverse to thelinking structure and with a spacer between the two screws. The entireprosthesis can be implanted percutaneously if desired. An illustrativeuse of the prosthesis is to shorten the annulus of a patient's mitralvalve, with at least a portion of the prosthesis implanted in thepatient's coronary sinus.

The following patents and patent application publications may be ofinterest:

-   -   PCT Publication WO 07/136783 to Cartledge et al.    -   PCT Publication WO 08/068756 to Gross et al.    -   PCT Publication WO 10/004546 to Gross et al.    -   PCT Publication WO 10/073246 to Cabiri et al.    -   U.S. Pat. No. 5,306,296 to Wright et al.    -   U.S. Pat. No. 6,569,198 to Wilson et al.    -   U.S. Pat. No. 6,619,291 to Hlavka et al.    -   U.S. Pat. No. 6,764,510 to Vidlund et al.    -   U.S. Pat. No. 7,004,176 to Lau    -   U.S. Pat. No. 7,101,395 to Tremulis et al.    -   U.S. Pat. No. 7,175,660 to Cartledge et al.    -   US 2003/0050693 to Quijano et al    -   US 2003/0167062 to Gambale et al.    -   US 2004/0024451 to Johnson et al.    -   US 2004/0148021 to Cartledge et al.    -   US 2005/0171601 to Cosgrove et al.    -   US 2005/0288781 to Moaddeb et al.    -   US 2007/0016287 to Cartledge et al.    -   US 2007/0080188 to Spence et al.    -   US 2007/0219558 to Deutsch    -   US 2007/0282375 to Hindrichs et al.    -   US 2008/0262609 to Gross et al.    -   US 2010/0161041 to Maisano et al.    -   US 2010/0161042 to Maisano et al.    -   US 2010/0211166 to Miller et al.

The following articles may be of interest:

O'Reilly S et al., “Heart valve surgery pushes the envelope,” MedtechInsight 8(3): 73, 99-108 (2006)

Dieter R S, “Percutaneous valve repair: Update on mitral regurgitationand endovascular approaches to the mitral valve,” Applications inImaging, Cardiac Interventions, Supported by an educational grant fromAmersham Health pp. 11-14 (2003)

SUMMARY OF THE INVENTION

In some applications of the present invention, a tissue anchor isprovided that is configured for receiving an implant and facilitatingimplantation of the implant. The anchor comprises a distal tissuecoupling element, e.g., a helical anchor, which penetrates tissue of apatient. The anchor also comprises a proximal implant-penetratingelement which receives and facilitates coupling of the implant to thetissue anchor. The implant-penetrating element comprises a post, whichextends between the proximal tip and the proximal end of the distaltissue coupling element. For some applications, the proximal tip of theimplant-penetrating element comprises a barb which punctures andreceives the implant.

Typically, during an open-heart, minimally-invasive, or transcatheterprocedure, a plurality of tissue anchors are implanted along an annulusof an atrioventricular valve of the patient, and are configured toreceive and facilitate implantation of a valve-repair implant, e.g., anannuloplasty ring or a prosthetic valve. Each anchor is reversiblycoupled to a cord, e.g., a suture or a wire, at a proximal end of theimplant-penetrating element. Prior to implantation of the valve-repairimplant, each cord is threaded through the implant, and the implant isthen slid toward the annulus along the cords. In response to continuedpushing of the valve-repair implant, the implant is then punctured atrespective locations by the proximal tips of each one of theimplant-penetrating elements. The physician continues to push thevalve-repair implant so that the implant slides along theimplant-penetrating elements and the posts of the anchors. The implantis pushed along the post until the proximal tips of each one of theimplant-penetrating elements are exposed from within the lumen of thevalve-repair implant and disposed proximally to a proximal surface ofthe implant. The valve-repair implant is then locked in place at thesurface of the implant that faces the lumen of the atrium of thepatient. Following the locking in place of the implant, the cords aredecoupled from the anchors and removed from within the body of thepatient.

In some applications of the present invention, a proximal restrainingelement, e.g., radially-expandable arms, is coupled to a proximalportion of the post of the anchor. This restraining element restrainsthe implant from separating from the implant-penetrating element.

In some applications of the present invention, an elastic portion, e.g.,a tension spring, is coupled at a proximal end to the proximal tip ofthe implant-penetrating element, and at a distal end to the proximal endof the post.

There is therefore provided, in accordance with some applications of thepresent invention, apparatus for use with an implant, the apparatusincluding:

-   -   a tissue anchor, which includes:        -   a distal tissue coupling element, which is configured to            penetrate cardiac tissue; and        -   a proximal implant-penetrating element configured to            penetrate the implant, the proximal implant-penetrating            element being shaped so as to define a passage therethrough,            which passage has at least two openings that are within 1 mm            of a proximal end of the implant-penetrating element; and    -   a cord configured to be removably passed through the passage.

In some applications of the present invention, the proximalimplant-penetrating element includes a post.

In some applications of the present invention, the post has a length ofbetween 1 and 7 mm and a greatest cross-sectional area of between 0.03mm{circumflex over ( )}2 and 0.2 mm{circumflex over ( )}2, which lengthis at least 4 times the square root of the greatest cross-sectionalarea.

In some applications of the present invention, the length of the post isat least 5 times the square root of the greatest cross-sectional area ofthe post.

In some applications of the present invention, the length of the post isat least 8 times the square root of the greatest cross-sectional area ofthe post.

In some applications of the present invention, the length of the post isat least 10 times the square root of the greatest cross-sectional areaof the post.

In some applications of the present invention, the length of the post isat least 15 times the square root of the greatest cross-sectional areaof the post.

In some applications of the present invention, the apparatus furtherincludes a proximal restraining element, which is configured to becoupleable to the post within 2 mm of a proximal end of the post, andwhich is configured to restrain the implant from separating from theimplant-penetrating element.

In some applications of the present invention, the proximal restrainingelement is shaped so as to define an opening therethrough, through whichthe cord is configured to pass.

In some applications of the present invention, the post defines aprotrusion configured to protrude into a plane of the implant and tocouple the implant to the tissue anchor.

In some applications of the present invention, the protrusion is shapedso as to define a distal shelf that has a transverse cross-sectionallength that is larger than a transverse cross-sectional length of theimplant-receiving element, the distal shelf being configured tofacilitate restricting of proximal motion of the implant along theprotrusion.

In some applications of the present invention, the proximal restrainingelement has a greatest cross-sectional area that is at least 1.5 times agreatest cross-sectional area of the post.

In some applications of the present invention, the apparatus furtherincludes a lock configured to be advanced toward the anchor and disposedbetween the implant and the proximal restraining element, the lockincluding:

-   -   a distal portion configured to rest against the implant, and    -   an expandable proximal portion having a cross-sectional area        during a resting state of the lock that is larger than the        greatest cross-sectional area of the post and smaller than the        greatest cross-sectional area of the proximal restraining        element.

In some applications of the present invention, the proximalimplant-penetrating element includes a barb configured to restrictproximal movement of the implant along the implant-penetrating element.

In some applications of the present invention, the barb includes aproximal restraining element which is configured to restrain the implantfrom separating from the implant-penetrating element.

In some applications of the present invention, the barb includes one ormore arms that are radially expandable to rest against an externalsurface of the implant following coupling of the implant to theimplant-penetrating element.

In some applications of the present invention, the arms are radiallycollapsible during at least a portion of the coupling of the implant tothe implant-penetrating element.

In some applications of the present invention, the proximalimplant-penetrating element includes an elastic portion that isconfigured to assume a first length when relaxed, and a second, greaterlength when under load.

In some applications of the present invention, the elastic portionincludes a tension spring.

In some applications of the present invention, the proximalimplant-penetrating element has a length of between 3 and 5 mm when theelastic portion is relaxed.

In some applications of the present invention, the implant-penetratingelement includes a proximal restraining element which is coupled to thepost, and which is configured to restrain the implant from separatingfrom the implant-penetrating element.

In some applications of the present invention, the proximal restrainingelement is coupled within 2 mm of a proximal end of the post.

In some applications of the present invention, the proximal restrainingelement is shaped so as to define an opening therethrough, through whichthe cord is configured to pass.

In some applications of the present invention, the proximal restrainingelement includes a protrusion configured to protrude into a plane of theimplant and to couple the implant to the tissue anchor.

In some applications of the present invention, the protrusion is shapedso as to define a distal shelf that has a transverse cross-sectionallength that is larger than a transverse cross-sectional length of theimplant-receiving element, the distal shelf being configured tofacilitate restricting of proximal motion of the implant along theprotrusion.

In some applications of the present invention, the proximal restrainingelement has a greatest cross-sectional area that is at least 1.5 times agreatest cross-sectional area of the post.

In some applications of the present invention, the apparatus furtherincludes a lock configured to be advanced toward the anchor and disposedbetween the implant and the proximal restraining element, the lockincluding:

-   -   a distal portion configured to rest against the implant, and    -   an expandable proximal portion having a cross-sectional area        during a resting state of the lock that is larger than the        greatest cross-sectional area of the post and smaller than the        greatest cross-sectional area of the proximal restraining        element.

I the proximal restraining element includes a barb configured torestrict proximal movement of the implant along the implant-penetratingelement.

In some applications of the present invention, the barb includes one ormore arms that are radially expandable to rest against an externalsurface of the implant following coupling of the implant to theimplant-penetrating element.

In some applications of the present invention, the arms are radiallycollapsible during at least a portion of the coupling of the implant tothe implant-penetrating element.

In some applications of the present invention, the proximalimplant-penetrating element includes an elastic portion that isconfigured to assume a first length when relaxed, and a second, greaterlength when under load.

In some applications of the present invention, the elastic portionincludes a tension spring.

In some applications of the present invention, the proximalimplant-penetrating element has a length of between 3 and 5 mm when theelastic portion is relaxed.

In some applications of the present invention, the coupling element isshaped so as to define a shape selected from the group consisting of: ahelix, a spiral, and a screw shaft.

In some applications of the present invention, the coupling element isshaped so as to define one or more radially-expandable prongs, theprongs being configured to expand and facilitate anchoring of thecoupling element and restrict proximal motion of the tissue anchor.

In some applications of the present invention, the apparatus furtherincludes the implant, the post is configured to couple the implant tothe anchor.

In some applications of the present invention, the implant includes anannuloplasty device.

In some applications of the present invention, the annuloplasty deviceincludes:

-   -   a sleeve having a lumen;    -   a spool coupled to the sleeve; and    -   a flexible contracting member that is coupled to the spool and        the sleeve, such that winding the contracting member around the        spool tightens the device.

In some applications of the present invention, the distal tissuecoupling element and the proximal implant-penetrating element includerespective elements that are coupled to one another.

In some applications of the present invention, the distal tissuecoupling element and the proximal implant-penetrating element arefabricated from a single piece.

There is additionally provided, in accordance with some applications ofthe present invention apparatus, including:

-   -   a tissue-repair implant configured to reside chronically in a        heart of a patient;    -   a tissue anchor including:        -   a distal tissue coupling element configured to couple the            tissue anchor to tissue of the heart of the patient; and        -   a proximal implant-receiving element configured to receive            at least a portion of the tissue-repair implant and            facilitate coupling of the tissue-repair implant to the            tissue anchor, the proximal implant-receiving element            including:        -   a proximal implant-restraining element coupled to a proximal            portion of the implant-receiving element, the proximal            implant-restraining element being configured to restrain the            implant from separating from the implant-receiving element.

In some applications of the present invention, the proximal restrainingelement includes a protrusion configured to protrude into a plane of theimplant and to couple the implant to the tissue anchor.

In some applications of the present invention, the protrusion is shapedso as to define a distal shelf that has a transverse cross-sectionallength that is larger than a transverse cross-sectional length of theimplant-receiving element, the distal shelf being configured tofacilitate restricting of proximal motion of the implant along theprotrusion.

In some applications of the present invention, the apparatus furtherincludes a cord removably couplable to the tissue anchor, the cord beingconfigured to facilitate passage of the implant therealong and towardthe tissue anchor.

In some applications of the present invention, the cord passes through aportion of the implant-receiving element.

In some applications of the present invention, the proximalimplant-receiving element includes a post.

In some applications of the present invention, the post has a length ofbetween 1 and 7 mm and a greatest cross-sectional area of between 0.03mm{circumflex over ( )}2 and 0.2 mm{circumflex over ( )}2, which lengthis at least 4 times the square root of the greatest cross-sectionalarea.

In some applications of the present invention, the length of the post isat least 5 times the square root of the greatest cross-sectional area ofthe post.

In some applications of the present invention, the length of the post isat least 8 times the square root of the greatest cross-sectional area ofthe post.

In some applications of the present invention, the length of the post isat least 10 times the square root of the greatest cross-sectional areaof the post.

In some applications of the present invention, the length of the post isat least 15 times the square root of the greatest cross-sectional areaof the post.

In some applications of the present invention, the proximalimplant-restraining element is coupled to the post within 2 mm of aproximal end of the post.

In some applications of the present invention, the proximalimplant-restraining element is shaped so as to define an openingtherethrough, through which the cord is configured to pass.

In some applications of the present invention, the proximalimplant-restraining element has a greatest cross-sectional area that isat least 1.5 times a greatest cross-sectional area of the post.

In some applications of the present invention, the apparatus furtherincludes a lock configured to be advanced toward the anchor and disposedbetween the implant and the proximal implant-restraining element, thelock including:

-   -   a distal portion configured to rest against the implant; and    -   an expandable proximal portion having a cross-sectional area        during a resting state of the lock that is larger than the        greatest cross-sectional area of the post and smaller than the        greatest cross-sectional area of the proximal        implant-restraining element.

In some applications of the present invention, the proximalimplant-restraining element includes a barb configured to restrictproximal movement of the implant along the implant-receiving element.

In some applications of the present invention, the barb includes one ormore arms that are radially expandable to rest against an externalsurface of the implant following coupling of the implant to theimplant-receiving element.

In some applications of the present invention, the arms are radiallycollapsible during at least a portion of the coupling of the implant tothe implant-receiving element.

In some applications of the present invention, the proximalimplant-receiving element includes an elastic portion that is configuredto assume a first length when relaxed, and a second, greater length whenunder load.

In some applications of the present invention, the elastic portionincludes a tension spring.

In some applications of the present invention, the proximalimplant-receiving element has a length of between 3 and 5 mm when theelastic portion is relaxed.

In some applications of the present invention, the distal tissuecoupling element is shaped so as to define a shape selected from thegroup consisting of: a helix, a spiral, and a screw shaft.

In some applications of the present invention, the distal tissuecoupling element is shaped so as to define one or moreradially-expandable prongs, the prongs being configured to expand andfacilitate anchoring of the coupling element and restrict proximalmotion of the tissue anchor.

In some applications of the present invention, the apparatus furtherincludes the implant, the implant-receiving element is configured tocouple the implant to the anchor.

In some applications of the present invention, the implant includes anannuloplasty device.

In some applications of the present invention, the implant includes:

-   -   a spool coupled to the tissue-repair implant; and    -   a flexible contracting member that is coupled to the spool and        the sleeve, such that winding the contracting member around the        spool tightens the contracting member.

In some applications of the present invention, the distal tissuecoupling element and the proximal implant-receiving element includerespective elements that are coupled to one another.

In some applications of the present invention, the distal tissuecoupling element and the proximal implant-receiving element arefabricated from a single piece.

There is also provided, in accordance with some applications of thepresent invention, the following inventive concepts:

-   1. A method comprising:    -   coupling, to cardiac tissue of a patient, a distal tissue        coupling element of a tissue anchor, which tissue anchor further        includes (a) a proximal implant-penetrating element, which is        shaped so as to define a passage therethrough, which passage has        at least two openings that are within 1 mm of a proximal end of        the implant-penetrating element, and (b) a cord, which is        removably passed through the passage;    -   passing the cord through an implant; and    -   advancing the implant over the cord until the implant reaches        and is penetrated by the proximal implant-penetrating element.-   2. The method according to inventive concept 1, wherein coupling the    distal tissue coupling element comprises:    -   coupling a distal tissue coupling element that comprises one or        more radially-expandable prongs configured to expand and        facilitate anchoring of the coupling element, and    -   by the coupling, restricting proximal motion of the tissue        anchor.-   3. The method according to inventive concept 1, wherein the proximal    implant-penetrating element includes a post, and wherein advancing    comprises advancing the implant until the implant reaches and is    penetrated by the post.-   4. The method according to inventive concept 3, further comprising    restraining the implant from separating from the implant-penetrating    element by coupling a proximal restraining element to the post    within 2 mm of the proximal end of the post.-   5. The method according to inventive concept 4, wherein restraining    the implant comprises advancing a lock along the cord to between the    implant and the proximal restraining element, the lock including (a)    a distal portion configured to rest against the implant, and (b) an    expandable proximal portion having a cross-sectional area at its    resting state that is larger than a greatest cross-sectional area of    the post and smaller than a greatest cross-sectional area of the    proximal restraining element.-   6. The method according to inventive concept 1, wherein the proximal    implant-penetrating element includes a barb, and wherein the method    further comprises restraining the implant from separating from the    implant-penetrating element by penetrating the barb through the    implant.-   7. The method according to inventive concept 6, wherein the barb    includes one or more arms that are radially expandable, and wherein    the method further comprises:    -   passing the one or more arms through the implant in a compressed        state thereof, and    -   restraining the implant from separating from the        implant-penetrating element by allowing the one or more arms to        expand and rest against an outer surface of the implant        following the penetrating of the barb through the implant.-   8. The method according to inventive concept 6, wherein the proximal    implant-penetrating element includes an elastic portion that is    configured to assume a first length when relaxed, and a second,    greater length when under load, and wherein penetrating the barb    through the implant comprises pulling the barb through the implant    by pulling on the cord.-   9. The method according to inventive concept 8, wherein the elastic    portion includes a tension spring.-   10. The method according to inventive concept 3, wherein the    proximal restraining element is coupled within 2 mm of the proximal    end of the post, and wherein restraining the implant from separating    from the implant-penetrating element comprises restraining the    implant from separating from the implant-penetrating element by the    proximal restraining element is coupled within 2 mm of the proximal    end of the post.-   11. The method according to inventive concept 3, further comprising    restraining the implant from separating from the implant-penetrating    element by a proximal restraining element that is coupled to a    proximal end of the post.-   12. The method according to inventive concept 11, wherein    restraining the implant comprises advancing a lock along the cord to    between the implant and the proximal restraining element, the lock    including (a) a distal portion configured to rest against the    implant, and (b) an expandable proximal portion having a    cross-sectional area at its resting state that is larger than a    greatest cross-sectional area of the post and smaller than a    greatest cross-sectional area of the proximal restraining element.-   13. The method according to inventive concept 11, wherein the    proximal implant-penetrating element includes a barb, and wherein    restraining the implant from separating from the implant-penetrating    element comprises penetrating the barb through the implant.-   14. The method according to inventive concept 13, wherein the barb    includes one or more arms that are radially expandable, and wherein    the method further comprises:    -   passing the one or more arms through the implant in a compressed        state thereof, and    -   restraining the implant from separating from the        implant-penetrating element by allowing the one or more arms to        expand and rest against an outer surface of the implant        following the penetrating of the barb through the implant.-   15. The method according to inventive concept 13, wherein the    proximal implant-penetrating element includes an elastic portion    that is configured to assume a first length when relaxed, and a    second, greater length when under load, and wherein penetrating the    barb through the implant comprises pulling the barb through the    implant by pulling on the cord.-   16. The method according to inventive concept 15, wherein the    elastic portion includes a tension spring.-   17. The method according to inventive concept 1, wherein coupling    comprises coupling the distal tissue coupling element to the tissue    at a site within a heart chamber of the patient, and wherein the    method further comprises, after the advancing of the implant over    the cord:    -   cutting the cord at a site outside of the heart chamber; and    -   withdrawing the cord from the passage.-   18. The method according to inventive concept 1, wherein coupling    comprises coupling the distal tissue coupling element to the tissue    at a site within a heart chamber of the patient, and wherein the    method further comprises, after the advancing of the implant over    the cord, withdrawing the cord from the passage.-   19. The method according to inventive concept 1, wherein the implant    includes an annuloplasty device, and wherein advancing the implant    comprises advancing the device over the cord until the device    reaches and is penetrated by the proximal implant-penetrating    element.-   20. The method according to inventive concept 19, wherein coupling    the distal tissue coupling element and advancing the device comprise    coupling and advancing during a transcatheter procedure.-   21. The method according to inventive concept 19, wherein advancing    the device comprises advancing the device into an atrium of a heart    of the patient in a vicinity of an annulus of an atrioventricular    valve.-   22. The method according to inventive concept 19, further comprising    tightening the annuloplasty device by winding a flexible contracting    member of the device around a spool coupled to the device.-   23. A method comprising:    -   coupling, to a first portion of cardiac tissue of a patient, a        distal tissue coupling element of a tissue anchor, which tissue        anchor further includes (a) a proximal implant-receiving        element, and (b) a cord, which is removably coupled to the        implant-receiving element;    -   passing the cord through a tissue-repair implant;    -   advancing the implant over the cord until the implant reaches        and is received at least in part by the proximal        implant-receiving element, the proximal implant-receiving        element comprising a proximal implant-restraining element; and    -   restraining the implant from separating from the        implant-receiving element by the proximal implant-restraining        element.-   24. The method according to inventive concept 23, wherein coupling    the distal tissue coupling element comprises:    -   coupling a distal tissue coupling element that comprises one or        more radially-expandable prongs configured to expand and        facilitate anchoring of the coupling element, and    -   by the coupling, restricting proximal motion of the tissue        anchor.-   25. The method according to inventive concept 23, wherein the    proximal implant-receiving element includes a post, wherein the    proximal implant-restraining element is coupled to a proximal    portion of the post, and wherein advancing comprises advancing the    implant until the implant reaches and is penetrated by the post.-   26. The method according to inventive concept 25, wherein the    proximal restraining element is coupled within 2 mm of the proximal    end of the post, and wherein restraining the implant from separating    from the implant-penetrating element comprises restraining the    implant from separating from the implant-penetrating element by the    proximal restraining element is coupled within 2 mm of the proximal    end of the post.-   27. The method according to inventive concept 25, wherein    restraining the implant comprises advancing a lock along the cord to    between the implant and the proximal restraining element, the lock    including (a) a distal portion configured to rest against the    implant, and (b) an expandable proximal portion having a    cross-sectional area at its resting state that is larger than a    greatest cross-sectional area of the post and smaller than a    greatest cross-sectional area of the proximal implant-restraining    element.-   28. The method according to inventive concept 23, wherein the    proximal implant-restraining element includes a barb, and wherein    the method further comprises restraining the implant from separating    from the implant-receiving element by penetrating the barb through    at least a portion of the implant.-   29. The method according to inventive concept 28, wherein the barb    includes one or more arms that are radially expandable, and wherein    the method further comprises:    -   passing the one or more arms through the implant in a compressed        state thereof, and    -   restraining the implant from separating from the        implant-receiving element by allowing the one or more arms to        expand and rest against an outer surface of the implant        following the penetrating of the barb through the implant.-   30. The method according to inventive concept 28, wherein the    proximal implant-receiving element includes an elastic portion that    is configured to assume a first length when relaxed, and a second,    greater length when under load, and wherein penetrating the barb    through the implant comprises pulling the barb through the implant    by pulling on the cord.-   31. The method according to inventive concept 30, wherein the    elastic portion includes a tension spring.-   32. The method according to inventive concept 23, wherein coupling    comprises coupling the distal tissue coupling element to the tissue    at a site within a heart chamber of the patient, and wherein the    method further comprises, after the advancing of the implant over    the cord:

cutting the cord at a site outside of the heart chamber; and

withdrawing the cord from the passage.

-   33. The method according to inventive concept 23, wherein coupling    comprises coupling the distal tissue coupling element to the tissue    at a site within a heart chamber of the patient, and wherein the    method further comprises, after the advancing of the implant over    the cord, withdrawing the cord from the tissue anchor.-   34. The method according to inventive concept 23, wherein coupling    the distal tissue coupling element and advancing the implant    comprise coupling and advancing during a transcatheter procedure.-   35. The method according to inventive concept 23, wherein advancing    the implant comprises advancing the device into an atrium of a heart    of the patient in a vicinity of an annulus of an atrioventricular    valve.-   36. The method according to inventive concept 23, further comprising    adjusting a distance between the first portion of cardiac tissue and    a second portion of cardiac tissue by winding a flexible contracting    member of the device around a spool coupled to the implant.-   37. The method according to inventive concept 23, wherein the    implant includes an annuloplasty device, and wherein advancing the    implant comprises advancing the device over the cord until the    device reaches and is penetrated by the proximal implant-receiving    element.-   38. The method according to inventive concept 37, further comprising    tightening the annuloplasty device by winding a flexible contracting    member of the device around a spool coupled to the device.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-F are schematic illustrations of a procedure for implanting atissue anchor for receiving a valve-repair implant, in accordance withsome applications of the present invention;

FIGS. 2A-C are schematic illustrations of the tissue anchor and adelivery tool therefor, in accordance with some applications of thepresent invention;

FIG. 3 is a schematic illustration of a plurality of the tissue anchorsof FIGS. 2A-C implanted along an annulus of a patient, in accordancewith some applications of the present invention;

FIG. 4 is a schematic illustration of a valve-repair implant beingadvanced toward the plurality of anchors of FIG. 3, in accordance withsome applications of the present invention;

FIGS. 5A-B, 6A-B, and 7 are schematic illustrations of respectivelocking mechanisms for each of the tissue anchors of FIGS. 3-4, inaccordance with some applications of the present invention;

FIGS. 8 and 9 are schematic illustrations of examples of valve-repairimplants which are received by the tissue anchors of FIGS. 3-4, inaccordance with respective applications of the present invention;

FIG. 10 is a schematic illustration of a tissue anchor for receiving avalve-repair implant, in accordance with another application of thepresent invention;

FIGS. 11A-D are schematic illustrations of a transcatheter procedure forimplanting a plurality of tissue anchors of FIG. 10, in accordance withsome applications of the present invention;

FIGS. 12-14 are schematic illustrations of a manipulator for implantingthe tissue anchors or FIGS. 2A-C and 10 during a minimally-invasive oropen-heart procedure, in accordance with some applications of thepresent invention;

FIGS. 15-18 are schematic illustrations of the implantation and lockingof the valve-repair implant during the minimally-invasive or open-heartprocedure, in accordance with some applications of the presentinvention;

FIG. 19 is a schematic illustration of the tissue anchor of FIGS. 2A-Cin accordance with some applications of the present invention; and

FIG. 20 is a schematic illustration of the tissue anchor of FIG. 10, inaccordance with some applications of the present invention.

DETAILED DESCRIPTION OF APPLICATIONS

Reference is now made to FIGS. 1A-F, 2A-C, and 3, which are schematicillustrations of a system 20 for implanting a tissue anchor 49, inaccordance with some applications of the present invention. FIGS. 1A-Fshow a transcatheter procedure for implanting tissue anchor 49. FIGS.2A-C show a transcatheter delivery tool 42 for delivering toward andimplanting anchor 49 at an implantation site, e.g., an annulus 25 of aheart 22 of a patient, as shown. Typically, the implantation siteincludes an annulus of an atrioventricular valve, e.g., a mitral valveor a tricuspid valve. It is to be noted that the implantation site isnot limited to a heart valve of the patient, and anchor 49 may beimplanted in other tissue of the patient, e.g., a portion of the innerwall of the heart of the patient, in a stomach of a patient, etc. Tissueanchor 49, as shown in FIG. 2B comprises a distal tissue couplingelement 50, e.g., a helical tissue anchor 58, and a proximalimplant-penetrating element 47 a. Proximal implant-penetrating element47 a comprises a post 52 a and a proximal implant-restraining element 53a which is configured to puncture and pass through a portion of avalve-repair implant, as will be described hereinbelow. Proximalrestraining element 53 a (i.e., a portion of implant-penetrating element47 a) is shaped so as to define a passage 56 therethrough. A cord 54 isremovably coupled to anchor 49 by being passed through passage 56. Cord54 functions to facilitate guiding of the valve-repair implant towardtissue anchor 49 implanted at annulus 25.

Reference is now made to FIGS. 1A-F, 2A-C, and 3-4 which are schematicillustrations of a procedure for implanting a plurality of tissueanchors 49 in order to repair a mitral valve 24 of the patient, inaccordance with some applications of the present invention. Mitral valve24 is shown including leaflets 26 and 28. The procedure is typicallyperformed with the aid of imaging, such as fluoroscopy, transesophagealecho, and/or echocardiography.

The procedure typically begins by advancing a semi-rigid guidewire 32into a right atrium of the patient, as shown in FIG. 1A.

As show in FIG. 1B, guidewire 32 provides a guide for the subsequentadvancement of a sheath 34 therealong and into the right atrium. Oncesheath 34 has entered the right atrium, guidewire 32 is retracted fromthe patient's body. Sheath 34 typically comprises a 14-20 F sheath,although the size may be selected as appropriate for a given patient.Sheath 34 is advanced through vasculature into the right atrium using asuitable point of origin typically determined for a given patient. Forexample:

-   -   sheath 34 may be introduced into the femoral vein of the        patient, through an inferior vena cava 30, into the right        atrium, and into a left atrium transseptally, typically through        the fossa ovalis;    -   sheath 34 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into the right        atrium, and into the left atrium transseptally, typically        through the fossa ovalis; or    -   sheath 34 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into the        right atrium, and into the left atrium transseptally, typically        through the fossa ovalis.

In some applications of the present invention, sheath 34 is advancedthrough an inferior vena cava 30 of the patient (as shown) and into theright atrium using a suitable point of origin typically determined for agiven patient.

(In this context, in the specification and in the claims, “proximal”means closer to the orifice through which system 20 is originally placedinto the body of the patient, and “distal” means further from thisorifice.)

Sheath 34 is advanced distally until the sheath reaches the interatrialseptum, as shown in FIG. 1C.

As shown in FIG. 1D, a resilient needle 38 coupled to an elongate wire36 and a dilator (not shown) are advanced through sheath 34 and intoheart 22. In order to advance sheath 34 transseptally into the leftatrium, the dilator is advanced to the septum, and needle 38 is pushedfrom within the dilator and is allowed to puncture the septum to createan opening that facilitates passage of the dilator and subsequentlysheath 34 therethrough and into the left atrium. The dilator is passedthrough the hole in the septum created by the needle. Typically, thedilator is shaped to define a hollow tube shaft for passage along needle38, and the hollow tube shaft is shaped to define a tapered distal end.This tapered distal end is first advanced through the hole created byneedle 38. The hole is enlarged when the gradually increasing diameterof the distal end of the dilator is pushed through the hole in theseptum.

The advancement of sheath 34 through the septum and into the left atriumis followed by the extraction of the dilator and needle 38 from withinsheath 34, as shown in FIG. 1E.

Subsequently, as shown in FIG. 1F, delivery tool 42 is advanced withinan advancement catheter 40 and through sheath 34. Delivery tool 42comprises an elongate tube shaft that is coupled at a distal end thereofto a manipulator 44. Manipulator 44 reversibly engages anchor 49 andfacilitates the delivery of anchor 49 to the left atrium and thesubsequent implantation of anchor 49 in tissue of annulus 25 of thepatient. Delivery tool 42 is described hereinbelow with reference toFIGS. 2A-C.

FIG. 2A shows delivery tool 42 disposed within advancement catheter 40,which slides through sheath 34 and toward annulus 25 of heart 22.Delivery tool 42, manipulator 44, and anchor 49 are shown incross-section.

FIG. 2B shows the relative spatial configurations of delivery tool 42,manipulator 44, and anchor 49. Anchor 49 comprises a distal tissuecoupling element 50 having a pointed distal tip 51 configured forpuncturing tissue of the patient. Distal tissue coupling element 50comprises a helical tissue anchor 58, by way of illustration and notlimitation, e.g., tissue coupling element 50 may comprise any suitabletissue anchor known in the art (e.g., as is shown hereinbelow in FIGS.19 and 20). For example, distal tissue coupling element 50 may compriseany suitable tissue anchor known in the art (e.g., a spiral or a screwshaft) or any tissue anchor as described in PCT Patent ApplicationPCT/IL2009/000593 to Gross et al., entitled, “Annuloplasty devices andmethods of delivery therefor,” filed Jun. 15, 2009, which published asWO 10/004546, and which is incorporated herein by reference.

Reference is now made to FIGS. 2A-B. The helical coils of helical tissueanchor 58 form a generally-cylindrical coil surrounding a lumen ofhelical tissue anchor 58. Helical tissue anchor 58 is shaped to providea bar 55 which projects into the lumen of helical tissue anchor 58. Adistal portion 57 of implant-penetrating element 47 a is coupled, e.g.,welded, to bar 55.

Reference is again made to FIG. 2B. Anchor 49, comprising distal tissuecoupling element 50 and implant-penetrating element 47 a, has a lengthL1 of 6-18, e.g., 6-12 mm, e.g., 10 mm. In some applications of thepresent invention, distal tissue coupling element 50 andimplant-penetrating element 47 a are separate pieces that are coupled,e.g., welded, to one another. Alternatively, distal tissue couplingelement 50 and implant-penetrating element 47 a are fabricated from asingle piece. Implant-penetrating element 47 a has a length L2 of 4-10mm, e.g., 5.5 mm. Distal tissue coupling element 50 has a length L3 of2-8 mm, e.g., 4 mm. Implant-penetrating element 47 a comprises a post 52a and proximal restraining element 53 a. Post 52 a has a length ofbetween 1 and 7 mm, e.g., 5.5 mm and a greatest cross-sectional area(measured at a plane that is perpendicular to the axis along which thelength of post 52 a is measured) of between 0.03 and 0.2 mm{circumflexover ( )}2, e.g., 0.13 mm{circumflex over ( )}2, which length is atleast 4 times (e.g., 5, 8, or 10 times) the square root of the greatestcross-sectional area. Post 52 a has a longest dimension at itscross-section of between 0.2 mm and 0.5 mm (e.g., 0.4 mm). That is, forexample, post 52 a has a length of 5.5 mm and a longest cross-sectionaldimension (measured at the plane that is perpendicular to the axis alongwith the length of post 52 a is measured) of 0.4 mm. In such an example,the ratio of the length to the longest cross-sectional dimension isaround 13.75:1. For some applications, this ratio is between 5:1 and14:1, and the ratio varies depending on the size of the implant that isanchored to the tissue of the patient via anchor 49.

It is to be noted that anchors 49 may be used to implant any implant ofany suitable size to any tissue of the patient, and that the ratio oflength to the longest cross-sectional dimension of post 52 a of between5:1 and 14:1 varies depending on the size of the implant that isanchored to the patient.

Proximal restraining element 53 a, is coupleable or coupled to post 52 awithin 2 mm of the proximal end of post 52 a. For some applications, asrecited above, implant-penetrating element 47 a comprises proximalrestraining element 53 a. Proximal restraining element 53 a has alongest dimension at its cross-section (measured at a plane that isperpendicular to the axis along which the length L1 is measured) ofbetween 0.3 mm and 0.75 mm, e.g., 0.6 mm. Proximal restraining element53 a has a greatest cross-sectional area of between 0.07 and 0.44mm{circumflex over ( )}2, (e.g., 0.28 mm{circumflex over ( )}2) that isat least 1.5 times a greatest cross-sectional area of post 52 a.Following the subsequent implantation of the valve-repair implant, aswill be described hereinbelow, proximal restraining element 53 arestrains the implant from sliding proximally along post 52 a andseparating from implant-penetrating element 47 a. Implant-penetratingelement 47 a is thus shaped to provide an elongate penetration having asufficient length-to-width ratio for penetrating the implant and forpassing through the lumen of the implant such that proximal restrainingelement 53 a is disposed proximally to the outer surface of the implant.In this configuration, proximal restraining element 53 a restrains theimplant from separating from implant-penetrating element 47 a, as isdescribed hereinbelow.

Proximal restraining element 53 a is shaped so as to define a passage 56therethrough, which passage has at least two openings that are within 1mm, e.g., such as 0.5 mm, of a proximal end of implant-penetratingelement 47 a. Cord 54 is looped through passage 56 and is therebyremovably coupled to anchor 49. As shown in FIG. 2C, the two portions ofcord 54 that project away from passage 56 of proximal restrainingelement 53 a, are joined, e.g., welded, together at site proximal totissue anchor 49, e.g., at a site outside the body of the patient, inorder to form a single proximal end portion 59 of cord 54. End portion59 of cord 54 is ultimately threaded through the implant outside thebody of the patient in order for the implant to be slid along cord 54and toward tissue anchor 49 at annulus 25. Once the implant is implantedat the annulus of the patient, cord 54 is cut distally to singleproximal end portion 59 so as to sever the loop created by the joiningof the two portions of cord 54 at end portion 59. Once cord 54 is cut,the physician extracts cord 54 from within the body of the patient as heor she pulls on proximal end portion 59 until cord 54 is pulled fromwithin passage 56 of proximal restraining element 53 a and is decoupledfrom anchor 49.

Reference is again made to FIG. 2A. As shown in the cross-sectionalillustration, delivery tool 42 and manipulator 44 are each shaped so asto define a central lumen for cord 54 that is coupled to proximalrestraining element 53 a of implant-penetrating element 47 a. Cord 54comprises a wire, a ribbon, a rope, or a band, which typically comprisesa flexible and/or superelastic material, e.g., nitinol, ePTFE, PTFE,polyester, stainless steel, or cobalt chrome. In some applications ofthe present invention, cord 54 comprises a braided polyester suture(e.g., Ticron). In some applications of the present invention, cord 54is coated with polytetrafluoroethylene (PTFE). In some applications ofthe present invention, cord 54 comprises a plurality of wires that areintertwined to form a rope structure.

Manipulator 44 is disposed at the distal end of the tube shaft ofdelivery tool 42 and is shaped to provide a distal applicator portion 46which has a smaller outer diameter than an outer diameter of a proximalportion of manipulator 44. As shown in the cross-sectional illustrationof manipulator 44 and anchor 49 in FIG. 2A, distal applicator portion 46is shaped so as to fit within a lumen of distal tissue coupling element50 (i.e., the outer diameter of portion 46 is smaller than an innerdiameter of distal tissue coupling element 50). Manipulator 44 is shapedso as to define a slit 48 which bisects the distal end portion ofmanipulator 44 into two lateral walled portions. Slit 48 functions as ahousing for housing and reversibly coupling implant-penetrating element47 a to delivery tool 42 (as shown in FIG. 2A). Slit 48 holds in placeanchor 49 as it is advanced toward annulus 25. Delivery tool 42 thenfunctions to implant distal tissue coupling element 50 of anchor 49 intissue of annulus 25. First, torque is delivered toward manipulator 44in response to rotation of the tube shaft of delivery tool 42.Responsively to the torque, the lateral walled portions at the distalportion of manipulator 44 and distal applicator portion 46 function as ascrew-driving tool by applying annular force to implant-penetratingelement 47 a and helical tissue anchor 58.

As shown in FIG. 2A, bar 55 of distal tissue coupling element 50functions to couple anchor 49 to manipulator 44 when bar 55 is receivedand disposed within slit 48 and surrounded by the lateral wall portionsof manipulator 44.

FIG. 3 shows a plurality of anchors 49 implanted in respective portionsof tissue of annulus 25 around a perimeter thereof. Each anchor 49 isimplanted such that a central longitudinal axis therethrough forms anangle of between about 45 and 90 degrees with a surface of the tissue ofannulus 25, such as between about 75 and 90 degrees, e.g., about 90degrees. The physician uses delivery tool 42, as described hereinaboveto systematically advance each anchor 49 through sheath 34 and towardannulus 25. A first anchor 49 is coupled to manipulator 44 of deliverytool 42, as follows: (a) cord 45 is fed through the lumen of the tubeshaft of delivery tool 42 and through the lumen of manipulator 44, and(b) distal applicator portion 46 of manipulator 44 is advanced withinthe lumen of helical tissue anchor 58, while (c) bar 55 of helicaltissue anchor 58 is advanced in place within slit 48 of manipulator 44.The relative spatial configurations anchor 49 and manipulator 44 whenanchor 49 is coupled to manipulator 44 is shown hereinabove withreference to FIG. 2A.

Delivery tool 42 is then fed within advancement catheter 40, andcatheter 40 is advanced within sheath 34 toward annulus 25 until adistal end of catheter 40 emerges from within the distal end of sheath34 and into the left atrium of the patient. Advancement catheter 40 isadvanced toward a given location along annulus 25. Subsequently, thetube shaft of delivery tool 42 is pushed such that distal tip 51 ofhelical tissue anchor 58 abuts the surface of tissue of the annulus.Torque is then delivered to manipulator 44 when the physician rotatesthe tube shaft of delivery tool 42 about a central axis of tool 42. Suchrotation of tool 42 rotates manipulator 44 in a manner in which thedistal walled portions of the distal end of manipulator 44 apply anannular force to helical tissue anchor 58. Responsively to the continuedapplication of the annular force to helical tissue anchor 58, distal tip51 punctures the tissue of annulus 25 and continues along a helical pathuntil helical tissue anchor 58 is corkscrewed sufficiently into tissueof annulus 25 at the given location. For applications in which distaltissue coupling element 50 comprises any other tissue coupling anchor,delivery tool 42 or any other delivery tool facilitates coupling ofanchor 49 to annulus 25 by advancing distal tissue coupling element 50into the tissue of annulus 25.

Following the corkscrewing of helical tissue anchor 58 into tissue ofthe annulus, the physician pulls slightly on the tube shaft of deliverytool 42. Upon applying the pulling force to tool 42, the tissue of theannulus responsively pulls on the corkscrewed distal tissue couplingelement 50, thereby pulling implant-penetrating element 47 a from withinslit 48 of manipulator 44 and disengaging anchor 49 from tool 42. Asimplant-penetrating element 47 a is pulled from and slides distallywithin slit 48, it frees anchor 49 from manipulator 44. Delivery tool42, freed from anchor 49, is then retracted within catheter 40, andcatheter 40 is extracted from within the body through sheath 34 whichremains in place for the subsequent advancements of the remaininganchors 49. As delivery tool 42 and catheter 40 are extracted, cord 45remains looped within passage 56 of proximal restraining element 53 aand is left disposed within sheath 34 such that proximal end portion 59of cord 54 is disposed and accessible outside the body of the patient.

Once outside the body of the patient, delivery tool 42 is then coupledto a second anchor 49 (as described hereinabove with reference to thecoupling of anchor 49 to manipulator 44), and tool 42 is fed intoadvancement catheter 40 which is then reintroduced into sheath 34. Thesecond anchor 49 is implanted, as described hereinabove. These steps arerepeated until all of the anchors have been implanted around annulus 25,as shown in FIG. 3. As shown, cords 45 reversibly coupled to each anchor49 are disposed within sheath 34 and are accessible at their respectiveproximal portions 59 at a site outside the body of the patient. It is tobe noted that although eight anchors 49 are implanted around annulus 25by way of illustration and not limitation, any suitable number ofanchors 49 may be implanted along annulus 25 according to the needs of agiven patient, e.g., depending on the level of distention and relaxationof the annulus of a given patient.

Reference is now made to FIG. 4, which is a schematic illustration of atissue-repair implant 60 being advanced along cords 54 toward annulus 25of the mitral valve of the patient. As shown, repair implant 60comprises a non-continuous, open, partial annuloplasty ring 300, by wayof illustration and not limitation. It is to be noted that anyvalve-repair device, or implant (e.g., a full annuloplasty ring, apartial annuloplasty ring, a prosthetic valve, or a docking station fora prosthetic valve such as an annular valve support member) may beadvanceable along cords 54. The partial, open ring of repair implant 60may be implemented using any one of the techniques described in U.S.patent application Ser. No. 12/341,960 to Cabiri, which issued as U.S.Pat. No. 8,241,351, and which is incorporated herein by reference.Typically, these techniques describe a full or partial ring comprising asleeve, a spool 302 coupled to the sleeve 304, and a flexiblecontracting member 306 that is coupled to the spool 302 and the sleeve304, such that (1) winding the contracting member 306 around the spool302 tightens the ring 300, and (2) unwinding the contracting member 306from around the spool 302 relaxes and expands the ring 300. As shown,implant 60 comprises a penetrable sleeve 304 comprising a braided fabricmesh. Implant 60 may also comprise a coiled implant in addition to orindependently of the sleeve 304.

Reference is made to FIGS. 2C and 4. Prior to the advancing of implant60, a respective proximal end portion 59 of each cord 54 is threadedthrough the material of repair implant 60. For example, end portion 59is threaded (a) through a first surface of implant 60, (b) through thelumen of implant 60 such that portion 59 passes orthogonal to thelongitudinal axis defined by the lumen of implant 60, and then (c)through an opposing surface of implant 60 such that it emerges proximalto the outer surface of implant 60. A pushing tool (not shown forclarity of illustration) is used to advance implant 60 throughadvancement catheter 40 (which is advanced through sheath 34) and alongeach cord 54 toward annulus 25. Once implant 60 emerges from withincatheter 40, the pushing tool is retracted and extracted from the body.Subsequently, implant 60 is locked in place along annulus 25 via anchors49, as is described hereinbelow.

FIGS. 5A-B show a locking mechanism 74 that comprises a lock 80 havingan annular distal portion 82 that is coupled to a plurality ofradially-collapsible prongs 84, in accordance with some applications ofthe present invention. Annular distal portion 82 has a diameter ofbetween 1.5 mm and 3 mm, e.g., 2.2 mm. Following the advancement ofmechanism 74 through the vasculature of the patient, lock 80 isultimately positioned at a proximal portion of post 52 a ofimplant-penetrating element 47 a at a site distal to implant-restrainingelement 53 a (FIG. 5B), as described hereinbelow.

It is to be noted that lock 80 also functions as a proximal restrainingelement to restrain implant 60 from sliding proximally away from anchor49 and annulus 25.

Locking mechanism 74 is coupled to a distal end of an advancement tube72 and is advanced toward annulus 25 of the patient while surrounded byan overtube 70. Locking mechanism 74 comprises a lock holder 73 whichhas radially-expandable arms 75 and 77. Each of arms 75 and 77 is shapedto define a respective slot 81 and 83 which each cup and receiverespective portions of annular distal portion 82 of lock 80, as shown inthe enlarged image of FIG. 5A. A distal portion of overtube 70 surroundsarms 75 and 77 during the advancement of locking mechanism 74 towardannulus 25 of the patient. Overtube 70 thus prevents arms 75 and 77 fromradially expanding, and this maintains coupling between holder 73 andlock 80. As shown, locking mechanism 74, advancement tube 72, andovertube 70 are advanced toward implant 60, along cord 54.

The distal ends of advancement tube 72 and overtube 70 are advanceduntil they contact a proximal surface of a portion of implant 60. Inresponse to continued pushing of tubes 70 and 72, tubes 70 and 72 pushthe portion of implant 60 distally such that implant 60 is penetrated byimplant-penetrating element 47 a (i.e., first by proximal restrainingelement 53 a and then by post 52 a). For some applications, proximalrestraining element 53 a is shaped to define a pointed tip, e.g., abarb, configure to puncture and penetrate a portion of implant 60. Onceimplant 60 is fully pushed, a distal surface of implant 60 contactstissue of annulus 25 and the proximal surface of implant 60 is disposeddistally to a distal end of proximal restraining element 53 a. Post 52 acouples implant 60 to anchor 49 by extending through a lumen of implant60.

It is to be noted that implant-penetrating element 47 a may penetratethe implant by penetrating a braided mesh surrounding the implant, maypenetrate the implant by passing between coils of a coiled implant,and/or may penetrate the implant in any other penetrating manner.

FIG. 5B shows the disengaging of lock 80 from mechanism 74 following thelocking in place of implant 60 to anchor 49 via lock 80. As describedhereinbelow, once lock 80 is coupled to anchor 49, overtube 70 is slidproximally with respect to advancement tube 72 such that arms 75 and 77of lock holder 73 are exposed from within the distal portion of overtube70. Once arms 75 and 77 are exposed, they expand radially (as is theirnatural tendency), and respective portions of annular distal portion 82of lock 80 are freed from within slots 81 and 83 of arms 75 and 77,respectively. Once lock 80 is freed from locking mechanism 74,advancement tube 72, locking mechanism 74, and overtube 70 are retractedfrom within the body of the patient. In conjunction with the retracting,cord 54 is clipped and pulled such that it is no longer looped withinpassage 56 of proximal restraining element 53 a. The physician continuesto pull cord 54 until cord 54 is extracted from within the body of thepatient.

FIGS. 6A-B and 7 show the method for locking repair implant 60 toannulus 25 via anchor 49, in accordance with some applications of thepresent invention. As shown, post 52 a of anchor 49 extends through thelumen of implant 60 from a distal surface of implant 60 (i.e., thesurface in contact with annulus 25) to an opposing surface at theproximal surface of implant 60 (i.e., the surface in communication withthe atrium of the patient). Post 52 a extends through the lumen ofimplant 60 in a manner in which a distal end of proximal restrainingelement 53 a is disposed proximally to the proximal surface of implant60.

Overtube 70 (and advancement tube 72, locking mechanism 74, and lock 80disposed in overtube 70) is advanced along cord 54 and toward anchor 49implanted at a given location along annulus 25. The distal end ofovertube 70 approaches the proximal surface of repair implant 60.Overtube 70 and advancement tube 72 are pushed so that locking mechanism74 and lock 80 engage implant-penetrating element 47 a of anchor 49. Astubes 70 and 72 are pushed, locking mechanism 74 is pushed towardimplant 60, and mechanism 74 in turn, pushes on annular distal portion82 of lock 80 in order to slide lock 80 distally and around proximalrestraining element 53 a. As annular distal portion 82 is pushed, prongs84 slide along proximal restraining element 53 a (FIG. 6A).

Typically, in their resting state, the proximal portions of prongs 84are aligned in a manner in which they form a circle at theircross-section having a longest dimension measured at a cross-section(measured at a plane that is perpendicular to the longitudinal axisalong which length L1 of implant 60 is measured) of between 0.25 mm and0.6 mm, (e.g., 0.45 mm) and a greatest cross-sectional area of between0.05 mm{circumflex over ( )}2 and 0.28 mm{circumflex over ( )}2, e.g.,0.16 mm{circumflex over ( )}2. It is to be noted that the proximalportions of prongs 84 are aligned in a manner in which they form acircle by way of illustration and not limitation, and that proximalportions of prongs 84 may be shaped so as to assume any given shape attheir cross-section having a greatest cross-sectional area during theresting state of between 0.05 mm{circumflex over ( )}2 and 0.28mm{circumflex over ( )}2, e.g., 0.16 mm{circumflex over ( )}2. Sinceproximal restraining element 53 a has a longest dimension at itscross-section of between 0.3 mm and 0.75 mm, as prongs 84 are advanceddistally over proximal restraining element 53 a proximal restrainingelement 53 a pushes the proximal portions of prongs 84 radially suchthat the proximal portions of prongs 84 expand from their resting stateto assume a greatest cross-sectional area of between 0.33 and 0.64mm{circumflex over ( )}2, i.e., a longest dimension at the cross-sectionof between 0.65 mm and 0.9 mm. As the proximal portions of prongs 84 areradially pushed, their collective cross-sectional area is larger thanthe greatest cross-sectional area of proximal restraining element 53 a.

In response to continued pushing of lock 80 by locking mechanism 74,lock 80 slides distally until the respective proximal ends of each prong84 are disposed distally to the distal end of proximal restrainingelement 53 a (shown in FIG. 6B). Since the greatest cross-sectional areaof post 52 a (i.e., between 0.03 mm{circumflex over ( )}2 and 0.2mm{circumflex over ( )}2) is smaller than the greatest cross-sectionalarea of proximal restraining element 53 a (i.e., between 0.07mm{circumflex over ( )}2 and 0.44 mm{circumflex over ( )}2), theproximal portions of prongs 84 radially collapse around post 52 a toassume a greatest cross-sectional area that is smaller than the greatestcross-sectional area of proximal restraining element 53 a. Since thegreatest cross-sectional area of proximal restraining element 53 a islarger than the greatest collective cross-sectional area of the proximalportions of prongs 84 in their resting state and as they surround post52 a, prongs 84 are restricted from moving proximally because they havecollapsed around post 52 a. That is, when lock 80 moves proximally alongpost 52 a, the proximal end portions of prongs 84 abut against thedistal end of proximal restraining element 53 a. In such a manner,proximal restraining element 53 a, restrains prongs 84 of lock 80 fromsliding proximally, and thereby proximal restraining element 53 a,together with lock 80, restrain implant 60 from sliding proximally awayfrom anchor 49 and from annulus 25. In such a manner, post 52 afunctions as a protrusion which protrudes into a plane defined byimplant 60, and the distal portion of proximal restraining element 53 afunctions as a shelf which facilitates restricting of proximal potion ofthe implant along the protrusion. As described herein above withreference to the cross-sectional area of proximal restraining element 53a (measured at a plane that is perpendicular to the longitudinal axisalong which length L1 of implant 60 is measured), the shelf has atransverse cross-sectional length (i.e., the cross-sectional area, asdescribed hereinabove), that is larger than a transverse cross-sectionallength of implant-penetrating element 47 a.

Additionally, as lock 80 is pushed distally, annular distal portion 82pushes against a portion of implant 60. Responsively, implant 60 pushesagainst annular distal portion 82 so as to (1) create pressure betweenthe proximal portions of prongs 84 and the distal end of proximalrestraining element 53 a, and (2) lock lock 80 in place with respect toproximal restraining element 53 a in order to restrain implant 60 fromsliding proximally.

FIG. 7 shows the decoupling of lock holder 73 from lock 80 and fromanchor 49. Overtube 70 is retracted proximally in order to expose arms75 and 77 of lock holder 73. Once arms 75 and 77 are exposed from withinovertube 70, they expand radially, as shown, and respective portions ofannular distal portion 82 of lock 80 are freed from within slots 81 and83 of arms 75 and 77, respectively. Overtube 70, advancement tube 72,and lock holder 73 are then retracted through sheath 34 along cord 54.

Reference is now made to FIGS. 2C and 7. Once lock 80 is locked in placebetween implant 60 and proximal restraining element 53 a of anchor 49,cord 54 is clipped distally to proximal end portion 59 thereof so as tocreate free ends of cord 54. A first free end of cord 54 is then pulledso that the second free end is pulled through advancement tube 72 andtoward anchor 49. In response to continued pulling of the first free endof cord 54, the second end of cord 54 is pulled through passage 56 ofproximal restraining element 53 a until cord 54 is decoupled from anchor49. The physician continues to pull on the first free end of cord 54until the second free end is once again exposed from within tube 72, andthereby cord 54 is extracted from within the body of the patient.

FIG. 7 shows the decoupling of lock holder 73 of locking mechanism 74from one of the eight anchors 49 around annulus 25. It is to be notedthat the method for the locking in place of implant 60 via anchors 49and locks 80 (as described hereinabove with reference to FIGS. 5A-B,6A-B, and 7) is applied to every anchor 49 implanted along annulus 25.FIG. 7 shows implant 60 comprising a partial, open, non-continuous ringas described in U.S. patent application Ser. No. 12/341,960 to Cabiri(which is incorporated herein by reference), by way of illustration andnot limitation. For example, any suitable tissue repair device known inthe art may be anchored to any tissue of the patient via anchor(s) 49.For example, anchors 49 may be implanted in a stomach of the patient andmay be used to anchor a gastric bypass ring to the stomach of thepatient, in a manner as described hereinabove.

FIGS. 8 and 9 are schematic illustrations of examples of the types ofimplants 60 that are anchored to annulus 25 via anchors 49, inaccordance with respective applications of the present invention. FIG. 8shows implant 60 comprising a partial, open, non-continuous annuloplastyring by way of illustration and not limitation. FIG. 9 shows a system110 in which implant 60 comprises a full annuloplasty ring by way ofillustration and not limitation. As described hereinabove implants 60,as shown in FIGS. 8 and 9, are shown by way of illustration and notlimitation and that any suitable tissue-remodeling device or implant maybe anchored to tissue of the patient using anchor(s) 49.

Reference is now made to FIG. 10, which is a schematic illustration of asystem 120 comprising a tissue anchor 121 comprising a distal tissuecoupling element 50 and a proximal implant-penetrating element 47 b, inaccordance with some applications of the present invention.Implant-penetrating element 47 b comprises a proximal elastic portioncomprising a tension spring 122 and a proximal restraining element 53 bcomprising radially-expandable anchor arms 128. Implant-penetratingelement 47 b comprises a proximal portion 124 shaped to define a pointedtip 126 for penetrating an implant (e.g., a tissue-repair implant 60)and facilitating passage of the implant over implant-penetrating element47 b. Typically, proximal portion 124, pointed tip 126, and arms 128together form and function as a barb 153. A proximal elastic portioncomprises a tension spring 122 (i.e., implant-penetrating element 47 b),as shown by way of illustration and not limitation, and has a length L4of between 3 mm and 5 mm, e.g., 4 mm, when spring 122 is relaxed.Radially-expandable arms 128 are compressible and expandable along alongitudinal axis 130 of anchor 121. Distal tissue coupling element 50comprises a distal tissue-penetrating tip 51 and is shaped to definehelical tissue anchor 58 by way of illustration and not limitation,e.g., tissue coupling element 50 may comprise any suitable tissue anchorknown in the art (e.g., as is shown hereinbelow in FIGS. 19 and 20).

It is to be noted that proximal implant-penetrating element 47 b ofanchor 121 is similar in function to proximal implant-penetratingelement 47 a of anchor 49 in that both proximal implant-penetratingelements 47 a and 47 b function to receive and facilitate coupling ofthe implant to the tissue anchor. It is to be further noted thatproximal restraining element 53 b of anchor 121 is similar in functionto proximal restraining element 53 a of anchor 49 in that both proximalrestraining elements 53 a and 53 b function to restrain the implant fromsliding proximally and separating from respective implant-penetratingelements 47 a and 47 b.

As described hereinabove, distal tissue coupling element 50 has lengthL3 of 2-8 mm, e.g., 4 mm. Thus, for some applications, anchor 121 has atotal length L5 of 5-13 mm.

The elastic portion is shown in FIG. 10 when spring 122 is in itsrelaxed, resting state. In this relaxed state of spring 122, the elasticportion has a length of between 3 and 5 mm. Spring 122 is configured tobe pulled during one stage of implantation of the tissue-repair device.During such pulling, spring 122 is under load and assumes a greaterlength when under load than when in its relaxed state.

The proximal portion of implant-penetrating element 47 b is shaped so asto define one or more passages 56 therethrough. It is to be noted thatonly one opening of one passage 56 is shown in the configuration asshown in FIG. 10, and that cord 54 passes through passage 56 on thesides of proximal portion 124. Cord 54 is removably coupled to anchor121 by being passed through passage 56 (as described hereinabove withreference to anchor 49) and functions to facilitate guiding of thevalve-repair implant toward tissue anchor 121 implanted at annulus 25.As described hereinabove, passage 56 has at least two openings that arewithin 1 mm, e.g., 0.5 mm, of a proximal end of implant-penetratingelement 47 b.

The distal portion of implant-penetrating element 47 b comprises a post52 b which couples distal tissue coupling element 50 to the elasticportion. Post 52 b in such an application has a height of between 0.2 mmand 0.4 mm. Anchor 121, comprising distal tissue coupling element 50 andimplant-penetrating element 47 b, has a length measured along axis 130of 6-12 mm, e.g., 10 mm. Implant-penetrating element 47 b has a lengthmeasured along axis 130 of 4-10 mm, e.g., 5.5 mm. Distal tissue couplingelement 50 has a length measured along axis 130 of 2-8 mm, e.g., 4 mm.For some applications, post 52 b includes spring 122, and in such anapplication, post 52 b has a length of between 1 and 7 mm.

FIG. 11A shows a plurality of tissue anchors 121 implanted along annulus25, in accordance with some applications of the present invention. Eachanchor 121 is reversibly coupled to an elongate delivery tool (not shownfor clarity of illustration) and is transcatheterally advanced via thetool toward annulus 25. The delivery tool facilitates corkscrewing ofhelical tissue anchor 58 into tissue of the annulus. For applications indistal tissue coupling element 50 comprises any other tissue couplinganchor, the delivery tool facilitates coupling of anchor 121 to annulus25 by advancing distal tissue coupling element 50 into the tissue ofannulus 25.

Each anchor 121 is implanted in a manner in which a proximal end oftissue coupling element 50 is disposed within tissue of annulus 25 and adistal end portion of spring 122 is disposed proximally to the surfaceof annulus 25, as shown in the enlarged image of tissue anchor 121 ofFIG. 11A. For some applications of the present invention, delivery tool42, as described hereinabove with reference to FIGS. 2A-C may bereversibly coupled to each anchor 121 and facilitate implantation ofeach anchor 121. In such an application, arms 128 of implant-penetratingelement 47 b are compressed within slit 48 of manipulator 44 of tool 42.

Once tissue anchor 121 is implanted, cord 54 remains coupled to anchor121, as described hereinabove with reference to the cord 54 coupled totissue anchor 49. It is to be noted that although eight anchors 121 areimplanted around annulus 25 by way of illustration and not limitation,any suitable number of anchors 121 may be implanted along annulus 25according to the needs of a given patient, e.g., depending on the levelof distention and relaxation of the annulus of a given patient.

Reference is now made to FIG. 11B, which is a schematic illustration ofa tissue-repair implant 60 being advanced along cords 54 toward annulus25 of the mitral valve of the patient. As shown, repair implant 60comprises a non-continuous, open, partial annuloplasty ring, by way ofillustration and not limitation. It is to be noted that any valve repairimplant, e.g., a full annuloplasty ring, a partial annuloplasty ring, ora prosthetic valve, may be advanceable along cords 54. The partial, openring of repair implant 60 may be implemented using any one of thetechniques described in U.S. patent application Ser. No. 12/341,960 toCabiri, which is incorporated herein by reference.

Implant 60 is advanced along cords 54, in a manner as describedhereinabove with reference to FIGS. 2C and 4. A pushing tool (not shownfor clarity of illustration) is used to push implant 60 through catheter40 and toward annulus 25. Implant 60 is pushed until respective portionsof a distal surface of implant 60 contact each pointed tip 126 ofproximal portion 124 of implant-penetrating element 47 b.

FIG. 11C shows a pushing tool 140, as described hereinabove withreference to FIG. 11B, that pushes respective portions of implant 60such that they are engaged by each implant-penetrating element 47 b ofanchors 121, in accordance with some applications of the presentinvention. Pushing tool 140 is advanced along a respective cord 54, asshown, and toward a portion of implant 60. The physician uses pushingtool 140 to push on the proximal surface of implant 60 such that thedistal surface of implant 60 is punctured by pointed tip 126 ofimplant-penetrating element 47 b. Continued pushing of pushing tool 140:(1) advances a portion of implant 60 around arms 128 and along theelastic portion and spring 122 of implant-penetrating element 47 b, andthereby (2) facilitates coupling of the portion of implant 60 to anchor121. As implant 60 is pushed, spring 122 compresses along axis 130 andprovides flexibility to system 120, as implant 60 is anchored to annulus25.

Following the puncturing of the distal surface of the portion of implant60 by pointed proximal tip 126 of implant-penetrating element 47 b, anopening is created at the distal surface of implant 60 for passagetherethrough of a proximal portion of implant-penetrating element 47 b.As implant 60 is pushed along implant-penetrating element 47 b, theproximal portion is disposed within the lumen of implant 60, as shown inthe enlarged image of FIG. 11C. The opening at the distal surface ofimplant 60 that is created by puncturing the material of implant 60closes around and radially compresses radially-expandable arms 128 asthe proximal portion of implant-penetrating element 47 b passes throughimplant 60 in conjunction with the pushing of implant 60 (as shown inthe enlarged cross-sectional images of implant 60 being coupled toanchor 121). Radially-expandable arms 128 are compressed such that theyalign alongside spring 122 as the portion of implant 60 is pushed alongimplant-penetrating element 47 b. Responsively to continued pushing ofthe portion of implant 60 by tool 140, pointed proximal tip 126 ofimplant-penetrating element 47 b punctures a proximal surface of theportion of implant 60 from within the lumen of implant 60, and proximaltip 126 emerges proximally to the proximal surface of implant 60.

Reference is now made to FIG. 11D, which is a schematic illustration ofthe locking in place of the portion of implant 60 at a given locationalong annulus 25 via arms 128 of anchor 121, in accordance with someapplications of the present invention. As described hereinabove,responsively to continued pushing of the portion of implant 60 by tool140, pointed tip 126 of implant-penetrating element 47 b punctures andcreates an opening at the proximal surface of implant 60 and emergesfrom within the lumen of implant 60 proximally to the upper surface ofimplant 60. Responsively to continued pushing of the portion of implant60 by tool 140, implant 60 slides along implant-penetrating element 47 bsuch that respective distal ends of arms 128 emerge from within thelumen of implant 60 and through the opening at the proximal surface ofthe portion of implant 60. Once arms 128 are freed from within the lumenof the portion of implant 60 (i.e., are no longer radially compressed bythe lumen of the portion of implant 60 and/or the respective openings atthe proximal and distal surfaces of the portion of implant 60), arms 128expand radially, as shown in the enlarged images of FIG. 11D. Arms 128are configured to radially compress and expand between 0 and 30 degreeswith respect to axis 130 of anchor 121. Arms 128 expand such that (1)the proximal ends thereof collectively form a perimeter that is largerthan the perimeter of the external surface of implant 60, and (2) arms128 lock in place around implant 60 to restrict proximal movement ofimplant 60.

Reference is now made to FIGS. 11C-D. Arms 128 expand around theexternal surface of implant 60 and thus function as proximal restrainingelement 53 b to restrain proximal sliding of implant 60 alongimplant-penetrating element 47 b and decoupling of implant 60 fromanchor 121 (FIG. 11D). Once arms 128 expand and lock in place theportion of implant 60 to annulus 25 via anchor 121, pushing tool 140 isextracted from the body of the patient through catheter 40. Spring 122is thus no longer compressed responsively to the pushing force ofimplant 60 applied by tool 140, and spring 122 relaxes and returns toits resting state (FIG. 11D). As shown in FIG. 11C, following thecoupling of respective portions of implant 60 to anchors 121, each cord54 coupled to the respective anchor 121 is cut, as described hereinabovewith reference to FIG. 2B, and decoupled from the respective anchor 121.Typically, but not necessarily, each cord 54 is decoupled from anchor121 immediately following the coupling of the respective portion ofimplant 60 to each anchor 121 (as shown in FIG. 11C). Alternatively,cords 54 remain coupled to respective anchors 121 until the entireimplant 60 is coupled to annulus 25 via anchors 121.

In some embodiments, in conjunction with the pushing of implant 60 bytool 140, cord 54 is pulled taut so as to apply load to spring 122 suchthat it expands to a length greater than its length during the restingstate of spring 122. The pulling of spring 122 helps pull arms 128through the lumen of implant 60 such that they emerge from within thelumen of implant 60. Once arms 128 emerge from within the lumen ofimplant 60, cord 54 is no longer pulled, and spring 122 returns to itsresting state in order to allow arms 128 to rest against an externalproximal surface of implant 60 and restrict proximal movement of implant60 along implant-penetrating element 47 b. Thus, arms 128 function asproximal restraining element 53 b, and arms 128 together with portion124 and tip 126 function as barb 153 b.

Reference is again made to FIG. 11C, which shows, by way of illustrationand not limitation, implant 60 being coupled to anchors 121 in asystematic order beginning from the left-most anchor 121, (i.e.,disposed at 10 o'clock) and moving clockwise in series from anchor toanchor. It is to be noted that implant 60 may be coupled to anchors 121in any suitable order (i.e., not in series from anchor to anchor), inaccordance with the protocol of the operating physician.

Reference is now made to FIGS. 12-14, which are schematic illustrationsof a system 200 for implanting anchors 49 and 121 described hereinabovein an open-heart or minimally-invasive procedure, in accordance withsome applications of the present invention. System 200 comprises a toolbody 202 and proximal handle portions 204 and 206. Tool body 202comprises an outer tube shaft 210 and an inner tube shaft 212 (FIG. 14).Inner tube shaft 212 functions similarly to the elongate tube shaft ofdelivery tool 42, as described hereinabove with reference to FIGS. 2A-C.The distal end of tube shaft 212 is coupled to manipulator 44 that isdescribed hereinabove with reference to FIGS. 2A-C. Manipulator 44 isreversibly coupled to anchor 49, as described hereinabove. It is to benoted that although FIGS. 12-14 show manipulator 44 coupled to anchor49, manipulator 44 may also be coupled to anchor 121, in a manner asdescribed hereinabove with reference to FIG. 11A. The proximal end ofinner tube shaft 212 is coupled to handle portion 206 of tool body 202.For some applications, handle portion 206 is rotatable along an axis 230of tool body 202 in order to (1) rotate inner tube shaft 212 and,thereby, rotate manipulator 44, and thereby (2) facilitate corkscrewingof distal tissue coupling element 50 of anchor 49 into tissue of annulus25. Alternatively, the entire tool body 202 is rotated about axis 230 oftool body 202 in order to rotate distal tissue coupling element 50 ofanchor 49 and facilitate corkscrewing of distal tissue coupling element50 of anchor 49 into tissue of annulus 25. In either application,following the corkscrewing of distal tissue coupling element 50 intotissue of annulus 25, anchor 49 is decoupled from manipulator 44, asdescribed hereinabove with reference to FIG. 2B, and thereby decoupledfrom tool body 202.

As shown in FIG. 14, inner tube shaft 212 is housed within a lumen ofouter tube shaft 210. Inner tube shaft 212 and handle portions 204 and206 are each shaped to provide a lumen for passage therethrough of cord54 coupled to anchor 49. Tool body 202 is shaped so as to provide (1) aproximal opening 214 for passage therethrough of cord 54, and (2) adistal opening 216 for passage therethrough of anchor 49. Once distaltissue coupling element 50 of anchor 49 is corkscrewed into tissue ofannulus 25 and anchor 49 is decoupled from manipulator 44, tool body 202is slid proximally along cord 54 leaving anchor 49 and a portion of cord54 in heart 22 of the patient.

FIG. 15 shows system 200 being used to implant anchor 49 in heart 22 ofthe patient, in accordance with some applications of the presentinvention during an open-heart or minimally-invasive procedure. In theseprocedures, an incision is created in heart 22 at the left atrium toprovide a passage for the distal end portion of tool body 202 to accessan atrial surface of the mitral valve. As shown, tool body 202 (or tubeshaft 212) is rotated in order to facilitate corkscrewing of distaltissue coupling element 50 of anchor 49 into tissue of annulus 25. Asdescribed hereinabove, pointed distal tip 51 punctures tissue of annulus25 in order to facilitate corkscrewing of distal tissue coupling element50 into tissue of annulus 25.

FIG. 16 shows a plurality of anchors 49 implanted along annulus 25following the corkscrewing of distal tissue coupling element 50 of eachanchor 49 into tissue of annulus 25, as facilitated by tool body 202 ofsystem 200 described hereinabove with reference to FIGS. 12-14, inaccordance with some applications of the present invention. It is to benoted that anchors 121, as described hereinabove with reference to FIGS.10 and 11A-D, may be implanted along annulus 25 using tool body 202 ofsystem 200. Following the implantation of each anchor 49 via tool body202, respective cords 54 remain coupled to each anchor 49. The proximalend portions of each cord 54 are accessible outside the body of thepatient.

As shown, each distal tissue coupling element 50 is disposed withintissue of annulus 25, and each proximal restraining element 53 a andpost 52 a of each anchor 49 extend proximally from the proximal surfaceof annulus 25. Each implant-penetrating element 47 a comprising proximalrestraining element 53 a and post 52 a is thus accessible by anytissue-repair implant 60 advanced theretoward along cord 54 reversiblycoupled to proximal restraining element 53 a.

FIG. 17 shows tissue-repair implant 60, as described hereinabove,coupled to annulus 25 via anchor 49, in accordance with someapplications of the present invention. As described hereinabove, implant60 is advanced along cords 54 toward tissue of annulus 25. A tool may beused to advance respective portions of implant 60 along each cord 54.Alternatively, during an open-heart procedure, the physician uses his orher fingers to push respective portions of implant 60 along each cord54. As shown in the enlarged image of FIG. 17, a portion of implant 60is coupled to anchor 49 in a manner in which: (1) the distal surface ofthe portion of implant 60 contacts the proximal surface of annulus 25,(2) a distal portion of post 52 a is disposed within the lumen ofimplant 60, and (3) a distal end of proximal restraining element 53 a isdisposed proximally to a proximal surface of the portion of implant 60.As shown, cords 54 remain coupled to anchors 49 following the couplingof the respective portions of implant 60 to implant-penetrating element47 a of each anchor 49.

FIG. 18 shows a tool system 220 for coupling a respective lock 80 to aportion of implant-penetrating element 47 a that is distal to proximalrestraining element 53 a of each anchor 49, in accordance with someapplications of the present invention. Tool system 220 comprises anouter tube shaft 228 which is shaped to provide a lumen for slidablemovement of an inner tube shaft 226. As shown in the enlargedcross-sectional image of FIG. 18, tube shaft 226 is shaped so as toprovide a lumen for passage therethrough of cord 54 in order tofacilitate sliding of tool system 220 along cord 54 and toward anchor49.

A distal end of inner tube shaft 226 is coupled to locking mechanism 74comprising lock holder 73, as described hereinabove with reference toFIGS. 5A-B. Thus, inner tube shaft 226 functions similarly toadvancement tube 72 (as described hereinabove with reference to FIGS.5A-B) in order to advance locking mechanism distally through outer tubeshaft 228. Outer tube shaft 228 functions similarly to overtube 70 (asdescribed hereinabove with reference to FIGS. 5A-B) in order to surroundradially-expandable arms 75 and 77 of locking mechanism 74 and maintainarms 75 and 77 in a compressed state within a distal portion of shaft228 during a resting state of system 220. As described hereinabove, lockholder 73 of locking mechanism 74 is reversibly coupled to a lock 80which locks in place a portion of implant 60 to annulus 25 via anchor49.

A proximal portion of inner tube shaft 226 is coupled to a firstengageable element 222, while a proximal end of outer tube shaft 228 iscoupled to a second engageable element 224. First and second engageableelements 222 and 224 are engageable by the hand of the operatingphysician. Tool system 220 is spring-loaded so as to facilitatecontrolled displacement of second engageable element 224 from firstengageable element 222. Responsively to pulling of second engageableportion element 224 away from first engageable element 222, outer tubeshaft 228 slides proximally along inner tube shaft 226.

Prior to the pulling of second engageable element 224, the operatingphysician pushes the entire tool system 220 (i.e., without pullingsecond engageable element 224 away from first engageable element 222)such that (1) the distal end of outer tube shaft 228 contacts theproximal surface of implant 60, and (2) lock 80 is pushed along proximalrestraining element 53 a and engages post 52 a, in a manner as describedhereinabove with reference to FIGS. 5A-B, 6A-B, and 7. The physicianthen pulls second engageable element 224 away from first engageableelement 222. In response to the pulling of engageable element 224 (i.e.,a pulled state of system 220), tube shaft 228 is pulled and a distalportion of lock holder 73 is exposed distally to the distal end of outertube shaft 228. Arms 75 and 77 are freed from within a distal endportion of outer tube shaft 228 and radially expand. Annular distalportion 82 of lock 80 is then freed from within slots 81 and 83 of arms75 and 77, respectively, and lock 80 is decoupled from locking mechanism74 and tool system 220. Once lock 80 is locked in place between implant60 and proximal restraining element 53 a, cord 54 is clipped distally toproximal end portion 59 thereof so as to create free ends of cord 54,and cord 54 is extracted from within the body of the patient, asdescribed hereinabove with reference to FIGS. 2C and 7.

As shown in the enlarged cross-sectional images of FIG. 18, a distalportion of post 52 a couples implant 60 to anchor 49 by being disposedwithin the lumen of implant 60 between a first opening of implant 60 ata distal surface thereof and a second opening of implant 60 at aproximal surface thereof.

Reference is now made to FIG. 19, which is a schematic illustration of asystem 320 comprising a tissue anchor 321 that is similar to tissueanchor 49, as described hereinabove, with the exception that distaltissue coupling element 50 comprises an expandable tissue anchor 322which comprises one or more, e.g., a plurality, of radially-expandableprongs 326, in accordance with some applications of the presentinvention. Prongs 326 comprise flexible metal, e.g., nitinol orstainless steel, and have a tendency to expand radially, as shown in theleft-most image in FIG. 19. Anchors 322 facilitate coupling of tissueanchor 321 to annulus 25 of the native valve, such as the mitral valveor the tricuspid valve, or to any other valve or tissue. Tissue anchor322 is shaped so as to define a pointed distal tip 324 configured topuncture tissue of annulus 25. As described hereinabove, distal tissuecoupling element 50, which, for this application of the presentinvention comprises tissue anchor 322, has length L3 of 2-8 mm, e.g., 4mm.

Tissue anchor 322 is coupled to (e.g., welded or otherwise coupled to)post 52 a of implant-penetrating element 47 a, as described hereinabove.Implant-penetrating element 47 a has length L2 of 4-10 mm, e.g., 5.5 mm.Taken together, tissue anchor 321 has length L1 of 6-18 mm, e.g., 10 mm.

In the right-side images of FIG. 19, tissue anchor 322 is shown beingimplanted into tissue of annulus 25. Pointed distal tip 324 puncturestissue of annulus 25. In response to distal pushing of anchor 321,tissue anchor 322 is pushed within tissue of annulus 25. As anchor 321is pushed, the force of the tissue of annulus 25 pushes against prongs326 and compresses prongs 326 inwardly (as shown in the upper-rightimage). Following the pushing of anchor 321 distally, anchor 321 ispulled slightly proximally (e.g., by pulling on cord 54) in order toenable prongs 326 to expand radially to assume a flower shape and alarger surface area, to restrict proximal motion of anchor 321 in tissueof annulus 25.

Following the implanting of anchor 322 within tissue of annulus 25, post52 a remains disposed proximally to a surface of annulus 25, so that itcan puncture and receive the implant, as described hereinabove.

FIG. 20 shows a system 420 comprising a tissue anchor 421 that issimilar to tissue anchor 121, as described hereinabove, with theexception that distal tissue coupling element 50 comprises an expandabletissue anchor 322, as described hereinabove with reference to FIG. 19,in accordance with some applications of the present invention. Asdescribed hereinabove, distal tissue coupling element 50, which, forthis application of the present invention comprises tissue anchor 322,has length L3 of 2-8 mm, e.g., 4 mm. Also, as described hereinabove,anchor 421 comprises a proximal elastic portion which comprises tensionspring 122, as shown by way of illustration and not limitation.Implant-penetrating element 47 b has a length L4 of between 3 mm and 5mm, e.g., 4 mm, when spring 122 is relaxed. Thus, for some applications,anchor 421 has a total length L5 of 5-13 mm.

Tissue anchor 421 comprises distal tissue coupling element 50 andproximal implant-penetrating element 47 b. As described hereinabove,implant-penetrating element 47 b comprises the proximal elastic portioncomprising tension spring 122 and proximal restraining element 53 bcomprising radially-expandable anchor arms 128. Implant-penetratingelement 47 b comprises a proximal portion 124 shaped to define a pointedtip 126 for penetrating an implant (e.g., a tissue-repair implant 60)and facilitating passage of the implant over implant-penetrating element47 b. Typically, proximal portion 124, pointed tip 126, and arms 128together form and function as a barb 153.

Reference is now made to FIGS. 19 and 20. For some applications of thepresent invention, during the delivery of anchors 321 and 421 towardannulus 25, a sheath (not shown) surrounds prongs 326 so as to keep themin a closed state and facilitate atraumatic advancement of prongs 326toward tissue at annulus 25.

Reference is now made to FIGS. 1A-F, 2A-C, 3-4, 5A-B, 6A-B, 7-10, 11A-D,and 12-20. It is to be noted that systems, methods, and anchors 49, 121,321, and 421 described herein may be used at any atrioventricular valve,e.g., the mitral valve or the tricuspid valve. It is to be further notedthat systems, methods, and anchors 49, 121, 321, and 421 describedherein may be implanted at any suitable tissue site (e.g., tissue of astomach of the patient) in order to facilitate implantation of anysuitable implant.

For some applications of the present invention, techniques describedherein are practiced in combination with techniques described in one ormore of the references cited in the Background section of the presentpatent application.

Additionally, the scope of the present invention includes applicationsdescribed in one or more of the following:

-   -   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral        Valve treatment techniques,” filed Mar. 15, 2006;    -   US Provisional Patent Application 60/873,075 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;    -   US Provisional Patent Application 60/902,146 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Feb. 16,        2007;    -   US Provisional Patent Application 61/001,013 to Gross et al.,        entitled, “Segmented ring placement,” filed Oct. 29, 2007;    -   PCT Publication WO 08/068756 to Gross et al., entitled,        “Segmented ring placement,” filed Dec. 5, 2007;    -   U.S. patent application Ser. No. 11/950,930 to Gross et al.,        entitled, “Segmented ring placement,” filed Dec. 5, 2007, which        published as US 2008/0262609, and which issued as U.S. Pat. No.        8,926,695;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as US        2010/0161041, and which issued as U.S. Pat. No. 8,147,542;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which issued as U.S. Pat. No. 8,715,342;    -   PCT Publication WO 10/004546 to Gross et al., entitled,        “Annuloplasty devices and methods of delivery therefor,” filed        on Jun. 15, 2009;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Sep. 21, 2009, which published as US 2010/0161042, and which        issued as U.S. Pat. No. 8,808,368;    -   PCT Publication WO 10/073246 to Cabiri et al., entitled,        “Adjustable annuloplasty devices and mechanisms therefor,” filed        Dec. 22, 2009;    -   U.S. patent application Ser. No. 12/706,868 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed Feb. 17, 2010,        which published as US 2010/0211166, and which issued as U.S.        Pat. No. 8,353,956;    -   PCT Patent Application PCT/IL2010/000357 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed        May 4, 2010, which published as WO 10/128502; and/or    -   PCT Patent Application PCT/IL2010/000358 to Zipory et al.,        entitled, “Deployment techniques for annuloplasty ring and        over-wire rotation tool,” filed May 4, 2010, which published as        WO 10/128503.

All of these applications are incorporated herein by reference.Techniques described herein can be practiced in combination withtechniques described in one or more of these applications.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1. A method, comprising: transluminally advancing an anchor of animplant to a heart of a subject, the anchor including a distal helicalelement, and a post extending proximally from the distal helicalelement; and anchoring the implant to tissue of the heart by: drivingthe distal helical element into the tissue, and compressing a fabrictube against the tissue by moving an annular member, coupled to thepost, toward the tissue such that the fabric tube becomes sandwichedbetween the annular member and the tissue.
 2. The method according toclaim 1, wherein a proximal part of the anchor defines a passagetherethrough, and wherein advancing the anchor of the implant comprisesadvancing the anchor of the implant while a cord extends through thepassage.
 3. The method according to claim 2, wherein driving the distalhelical element into the tissue of the heart comprises driving thedistal helical element into the tissue of the heart while the cordcontinues to extend through the passage.
 4. The method according toclaim 2, further comprising, subsequently to anchoring the implant tothe tissue, sliding the cord through the passage.
 5. The methodaccording to claim 2, wherein the cord includes nitinol, and whereinadvancing the anchor of the implant comprises advancing the anchor ofthe implant while the cord that includes nitinol extends through thepassage.
 6. The method according to claim 1, wherein compressing thefabric tube against the tissue comprises compressing the fabric tubeagainst the tissue while the post extends through the fabric tube. 7.The method according to claim 1, wherein: the post is coaxial with alongitudinal axis of the anchor, the distal helical element curveshelically around the longitudinal axis, and driving the distal helicalelement into the tissue comprises driving, into the tissue, the distalhelical element that curves helically around the longitudinal axis. 8.The method according to claim 1, wherein the distal helical element andthe post are fabricated from a single piece, and wherein transluminallyadvancing the anchor comprises transluminally advancing the anchor thatincludes the distal helical element and the post that are fabricatedfrom the single piece.
 9. The method according to claim 1, wherein theannular member has a diameter of 1.5-3 mm, and wherein compressing thefabric tube against the tissue comprises compressing the fabric tubeagainst the tissue by moving the annular member that has the diameter of1.5-3 mm toward the tissue such that the fabric tube becomes sandwichedbetween the annular member and the tissue.
 10. The method according toclaim 1, wherein the anchor is 6-18 mm long, and wherein transluminallyadvancing the anchor to the heart comprises transluminally advancing, tothe heart, the anchor that is 6-18 mm long.
 11. The method according toclaim 1, wherein the post is 1-7 mm long, and wherein transluminallyadvancing the anchor to the heart comprises transluminally advancing, tothe heart, the anchor that includes the post that is 1-7 mm long. 12.The method according to claim 1, wherein the post is 0.2-0.4 mm long,and wherein transluminally advancing the anchor to the heart comprisestransluminally advancing, to the heart, the anchor that includes thepost that is 0.2-0.4 mm long.
 13. The method according to claim 1,wherein the distal helical element is 2-8 mm long, and wherein drivingthe distal helical element into the tissue comprises driving, into thetissue, the distal helical element that is 2-8 mm long.